This invention is concerned with improvements in and relating to sustained release compositions and, more particularly, is concerned with sustained release orally administrable dosage unit forms containing morphine, or a pharmaceutically acceptable salt thereof, as active ingredient.
The present invention also relates generally to a method of manufacturing an orally administrable dosage form, preferably sustained release granules/multiparticulates and compressed multiparticulates, such multiparticulates having diameters ranging from 0.1 to 3.0 mm; the method of the invention provides multiparticulates in an unexpectedly high yield.
Morphine is an opioid analgesic well established for use in the treatment of pain, especially moderate to severe pain. Morphine-containing compositions in sustained release form are currently commercially available as so-called "twice-a-day" formulations, that is formulations having a duration of activity of 12 hours or more and accordingly requiring to be administered twice a day.